BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAIPH CEMENTED PATELLA

    MDR report key: 23376983 · Received October 24, 2025

    Report

    Report Number
    3016096064-2025-00001
    Event Type
    Malfunction
    Date Received
    October 24, 2025
    Date of Event
    October 13, 2025
    Report Date
    October 16, 2025
    Manufacturer
    MATORTHO
    Product Code
    KRP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS THE FIRST INSTANCE OF THIS KIND OF FAILIURE THERE HAVE BEEN NO OTHER SIMILAR REPORTS BEFORE OR SINCE, BATCH RECORDS WERE REVIEWED AND THERE WERE NO REPORTED ISSUES ON THE DOCUMENTATION.

    Description of Event or Problem · 0

    ATTENDED A REVISON CASE FOR A PATELLA WHICH WAS IMPLANTED ON (B)(6) 2017 BY DR (B)(6). THE PATELLA RECENTLY / POTENTIALLY EXPERIENCED A SHEAR FORCE OF UNKNOWN CIRCUMSTANCE LEADING TO THE PATELLA BUTTON BEING BROKEN OFF FROM ITS POLY PEGS/STEMS WITH THE PEGS REMAINING INTACT WITHIN THE BONE. DR (B)(6) THEREFORE BOOKED THE PATIENT IN FOR A REVISON OF THE PATELLA BUTTON AND REPLACED THE PATELLA ON (B)(6) 25 WITH ANOTHER 34MM CEMENTED SAIPH PATELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243473 SAIPH CEMENTED PATELLA SAIPH CEMENTED PATELLA KRP MATORTHO 190-113 218476

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male